The QA Operations Specialist II – Floor Support D Shift (Wed – Sat) 3:30 PM till 2:00 AM
Core
Provide on-the-floor Quality Assurance oversight for manufacturing and visual inspection of clinical and commercial drug products in a GMP facility.
Role type
Senior IC QA Operations Specialist (Manufacturing)
Builds
GMP-compliant drug products for biopharma clients
Domain
Biopharmaceuticals / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, AQL visual inspection, root cause analysis, deviation/CAPA initiation, SOP review, material disposition, audit support, technical writing, risk management tools
Preferred skills
Lean operation excellence, FDA regulations (21CFR Part 210, 211 & 820), ICH guidelines, Risk Management Tools (FMEA, HACCP, PHA), ASQ certification
Technologies
GMP documentation systems, batch record software, risk management tools
Responsibilities
Perform real-time QA oversight of formulation and aseptic processes; conduct AQL visual inspection of finished drug product vials; review and approve batch records and incoming raw materials; initiate and manage deviations, CAPA, and nonconformances; perform root cause analysis using fishbone and 5 whys; support internal and regulatory audits; coach personnel on cGMP compliance and documentation.
Seniority
Mid-level, hands-on IC